MX2008008467A - Process of making electrolessly plated auto-calibration circuits for test sensors - Google Patents

Abstract

A method of forming an auto-calibration circuit to be used with a sensor package. The sensor package includes at least one test sensor and is adapted to be used with an instrument or meter. A substrate is provided. Catalytic ink or catalytic polymeric solution is applied to at least one side of the substrate to assist in defining electrical connections on the substrate. The substrate is electrolessly plated with the catalytic ink or catalytic polymeric solution to form the electrical connections of the substrate. The electrical connections convey auto-calibration information for the at least one test sensor to the instrument.

Description

PROCESS OF MANUFACTURE OF CIRCUITS OF AUTOMATIC CALIBRATION COATED BY CHEMICAL FOR TEST SENSORS Field of the Invention The present invention relates, in general, to a manufacturing process of automatic calibration circuits for test sensors. More specifically, the process is aimed at the manufacture of automatic calibration circuits by chemical means for test sensors, which are adapted to be used to calibrate instruments or meters that determine the concentration of an analyte (for example, glucose ) in a fluid.

Background of the Invention The quantitative determination of analytes in bodily fluids is of great importance in the diagnosis and maintenance of certain physiological abnormalities. For example, lactate, cholesterol and bilirubin have to be monitored in certain individuals. In particular, it is important that diabetic individuals frequently check the level of glucose in their body fluids for the purpose of regulating the entry of glucose into their diets. The results of these tests can be used to determine, if any, which insulin or other medication It needs to be managed. In a type of blood glucose check or verification system, sensors are used to test a blood sample. A test sensor contains biosensing or reagent material that reacts with blood glucose. The test end of the sensor is adapted to be placed within the fluid being tested, for example, blood that has accumulated on the person's finger once the finger has been punctured. The fluid is extracted within a capillary channel that extends in the sensor from the test end to the reactive material by the action of capillarity, so that a sufficient amount of fluid will be extracted to the sensor to be tested. Then, the fluid reacts chemically with the reactive material in the sensor causing an electrical signal indicative of the glucose level in the fluid being tested. This signal is supplied to the meter by means of contact areas located next to the rear or contact end of the sensor and becomes the measured output. Diagnostic systems, such as blood glucose test systems, usually calculate the current value of glucose based on the measured output and known reactivity of the reagent detection element (test sensor) used to perform the test. proof. The Reactivity information or batch calibration of the test sensor could be given to the user in several ways that include a number or character that they enter into the instrument. A method of the prior art included, uses an element that is similar to a test sensor, although it was capable of being recognized as a calibration element by the instrument. The information of the test element is read by the instrument or a memory element that is connected to the microprocessor card of the instrument for direct reading of the test element. These methods experience the disadvantage of depending on the user to enter the calibration information, which some users could not do. In this case, the test sensor could use wrong calibration information and in this way, it would return an erroneous result. The . Improved systems use an automatic calibration circuit that is associated with the sensor package. The automatic calibration circuit is read automatically when the sensor pack is placed in the meter and does not require user intervention. A current method of forming a metal circuit for automatic calibration is by rolling a substrate with a thin sheet of metal followed by a subtractive chemical attack process that defines the electrical connections. This process tends to be more expensive that is necessary because a portion of the metallic material is removed from the substrate and therefore, is not present in the finalized automatic calibration circuit. It would be desirable to provide a method for forming an automatic calibration circuit that is more cost effective than existing processes, while still being an efficient process.

SUMMARY OF THE INVENTION According to one method, an automatic calibration circuit is formed that will be used with a sensor package. The sensor pack includes at least one test sensor and is adapted so that it is used with an instrument or meter. A substrate is provided. A catalytic ink or catalytic polymer solution is applied to at least one side of the substrate. Catalytic ink or catalytic polymer solution is used to help define the electrical connections in the substrate. The substrate is coated chemically, where the catalytic ink or catalytic polymer solution was applied to form the electrical connections of the substrate. The electrical connections carry the automatic calibration information from at least one test sensor to the instrument. According to another method, a circuit is formed of automatic calibration that will be used with a sensor package. The sensor pack includes at least one test sensor and is adapted so that it is used with an instrument or meter. A substrate is provided. At least one opening is formed through the substrate. Catalytic ink or catalytic polymer solution is applied on two opposite sides of the substrate. Catalytic ink or catalytic polymer solution is used to help define the electrical connections in the substrate. The substrate is chemically coated where the catalytic ink or catalytic polymer solution was applied to form the electrical connections of the substrate. The electrical connections carry the automatic calibration information from at least one test sensor to the instrument. According to a further method, a sensor packet is formed, which is adapted so that it is used with at least one instrument to determine the analyte concentration in a fluid sample. A substrate is provided. Catalytic ink or catalytic polymer solution is applied to at least one side of the substrate. Catalytic ink or catalytic polymer solution is used to help define the electrical connections in the substrate. The substrate is coated chemically where the catalytic ink or polymer solution Catalytic was applied to form the electrical connections of the substrate. The electrical connections carry the automatic calibration information from at least one test sensor to the instrument. The automatic calibration circuit is connected to a surface of the base of the sensor package. At least one test sensor is provided which is adapted to receive the fluid sample and can be operated with at least one instrument.

Brief Description of the Figures Figure 1 is a top perspective view of a detection instrument according to one embodiment. Figure 2 is a top perspective view of the interior of the detection instrument of Figure 1. Figure 3 is a sensor package according to one embodiment for use with the detection instrument of Figures 1 and 2. Figure 4 is a top view of an automatic calibration label or circuit formed by the method of the present invention. Figure 6 is a top view of an automatic calibration circuit formed by another method of the present invention. Figure 7 is a top view of the automatic calibration circuit of Figure 6 according to a Pattern. Figure 8a is a top perspective view of a substrate that is used to form the automatic calibration circuit of Figure 4 according to a process. Figure 8b is the substrate of Figure 8a with a catalytic ink or catalytic polymer solution that is being added thereto according to a process. Figure 8c is the substrate with the catalytic ink or catalytic polymer solution of Figure 8b that is being exposed to ultraviolet light. Figure 8d is a side view of a bath that is adapted to chemically coat the substrate with a chemical coated solution after it is exposed to ultraviolet light of Figure 8c. Figure 9a is a top perspective view of a substrate that is used to form an automatic calibration circuit according to another process. Figure 9b is the substrate of Figure 9a with a plurality of openings formed therein. Figure 9c is a top perspective view of the substrate of Figure 9b with a catalytic ink or catalytic polymer solution being added thereto. Figure 9d is a bottom perspective view of the substrate of Figure 9b with a catalytic ink or catalytic polymer solution being added thereto. Figure 9e is a top perspective view of the substrate with a catalytic ink or catalytic polymer solution of Figures 9c, 9d that is being exposed to ultraviolet light. Figure 9f is a bath that is adapted to chemically coat the substrate with a solution coated chemically after being exposed to ultraviolet light of Figure 9e. Figure 10a is an enlarged side view of an opening shown in Figure 9b once the catalytic ink or catalytic polymer solution has been applied to the substrate. Figure 10b is an enlarged side view of the opening shown in Figure 10a once the substrate has been coated chemically.

Detailed Description of the Illustrated Modalities An instrument or meter in a modality uses a test sensor adapted to receive a sample of fluid to be analyzed, and a processor is adapted to perform a predefined test sequence to measure the predefined value of the parameter. A memory is connected to the processor to store the pre-defined values of parameter data. The calibration information associated with the test sensor could be read by the processor before the fluid sample to be measured is received. The calibration information could be read by the processor once the fluid sample to be measured is received, but not after the concentration of the analyte has been determined. The calibration information is used to measure the predefined value of the parameter data in order to compensate for the different characteristics of the test sensors, which will vary on a batch-lot basis. Variations of this process will be apparent to those of ordinary skill in the art from the teachings described in this document, which include but are not limited to the figures. Next, with reference to Figures 1-3, an instrument or meter 10 is illustrated. In Figure 2, the interior of instrument 10 is shown in the absence of a sensor pack. An example of a sensor pack (sensor pack 12) is illustrated separately in Figure 3. With reference back to Figure 2, a base member 14 of the instrument 10 supports an automatic calibration plate 16 and a predetermined number of automatic calibration bolts 18. As shown in Figure 2, for example, instrument 10 includes ten bolts of automatic calibration 18. It is contemplated that the number of automatic calibration bolts could vary in the number and shape of those shown in Figure 2. The automatic calibration bolts 18 are connected for coupling with the sensor package 12. The Sensor pack 12 of Figure 3 includes an automatic calibration tag or circuit 20, a plurality of test sensors 22 and a sensor packet base 26. The plurality of test sensors 22 is used to determine the analyte concentrations. Analytes that could be measured include glucose, lipid profiles (eg, cholesterol, triglycerides, LDL and HDL), microalbumin, hemoglobin A? C, fructose, lactate or bilirubin. It is contemplated that other concentrations of analytes could be determined. The analytes could be, for example, in a complete sample of blood, a sample of blood serum, a sample of blood plasma, other body fluids such as ISF (interstitial fluid) and urine, and non-bodily fluids. As used within this application, the term "concentration" refers to the concentration of analyte, activity (eg, enzymes and electrolytes), titers (eg, antibodies) or any other concentration of measurement that is used to measure the desired analyte. In one embodiment, the plurality of sensors of Test 22 includes an enzyme selected suitably to react with the analyte or desired analytes to be tested. An enzyme that could be used to react with glucose is glucose oxidase. It is contemplated that other enzymes could be used such as glucose dehydrogenase. An example of a test sensor is described in U.S. Patent No. 6,531,040, assigned to Bayer Corporation. It is contemplated that other test sensors could be used. The calibration information or the codes assigned for use in the calculations of the clinical value in order to compensate for the manufacture of the variations between the sensor lots are coded in the automatic calibration circuit 20. The automatic calibration circuit 20 is used to automate the process of transferring the calibration information (for example, the reagent calibration information specific to the plurality of test sensors 22), so that the sensors 22 could be used with at least one instrument or meter. In one embodiment, the automatic calibration circuit 20 is adapted so that it is used with different instruments or meters. The automatic calibration bolts 18 are electrically connected to the automatic calibration circuit 20 when a cover 38 of the instrument 10 is closed and the circuit 20 is closed.

I presented. The automatic calibration circuit 20 will be discussed in detail in connection with Figure 4. According to one method, an analyte concentration of a fluid sample is determined using electrical current readings and at least one equation. In this method, the constants of the equation are identified using the calibration information or the codes of the automatic calibration circuit 20. These constants could be identified by (a) the use of an algorithm to calculate the constants of the equation or (b) ) retrieving the constants from the equation of a lookup table for a particular predefined calibration code that is read from the automatic calibration circuit 20. The automatic calibration circuit 20 could be implemented through digital or analog techniques. In a digital implementation, the instrument helps determine if there is a conductance across the selected locations in order to establish the calibration information. In an analog implementation, the instrument helps to measure the resistance throughout the selected locations in order to determine the calibration information. With reference back to Figure 3, the plurality of test sensors 22 is located around the automatic calibration circuit 20 and extends in radial direction from the area containing the circuit 20. The plurality of sensors 22 of Figure 3 is stored in individual cavities or ampoules 24 and read by a set of associated electronic circuits of the sensor before one of the plurality is used. of test sensors 22. The plurality of sensor cavities or blisters 24 extend towards a peripheral edge of the sensor pack 12. In this embodiment, each sensor cavity 24 accommodates one of the plurality of test sensors 22. The sensors 12 of Figure 3 has a generally circular shape with the sensor cavities 24 extending from the outer peripheral edge towards and away from the center of the sensor package 12. However, it is contemplated that the sensor package could be different shapes of the one represented in Figure 3. For example, the sensor pack could be of square shape, of rectangle or other polygonal shapes or shapes. or polygonal ones that include the oval shape. With reference to Figure 4, the automatic calibration circuit 20 in this embodiment is adapted so that it is used with (a) the instrument or meter 10, (b) a second instrument or meter (not shown) that is different or different from the instrument 10, and (c) the plurality of sensors 22 that can be operated with both the instrument 10 and the second instrument. In this way, in this The automatic calibration circuit 20 could be considered "backward" compatible because it is adapted so that it is used with the second instrument (ie, a new instrument) and the first instrument (ie, the previous instrument). The automatic calibration circuit could be used to work with two earlier instruments or with two newer instruments. In order to reduce or avoid manufacturing modifications, it is desirable that a "backward" compatible automatic calibration circuit does not increase the size of the circuit or decrease the size of the electrical contact areas. In another embodiment which will be discussed below in connection with Figures 6 and 7, an automatic calibration circuit is adapted to be used with an instrument. According to one embodiment, the sensor pack contains a plurality of sensors that can be operated with at least one instrument (e.g., the sensor pack 12 containing a plurality of sensors 22 that can be operated with the instrument 10 and the second instrument). When the plurality of sensors 22 have the same calibration characteristics, the calibration of the instrument 10 for one of the sensors 22 is effective to calibrate the instrument 10 for each of the plurality of sensors 22 in this particular package 12.

The automatic calibration circuit 20 of Figure 4 includes an inner ring 52, an outer ring 54, a plurality of electrical connections 60 and a plurality of electrical connections 62 distinct from the plurality of electrical connections 60. For some applications, the inner ring 52 represents the logical Os and the outer ring 54 represents the logical ls. It is contemplated that the inner ring or outer ring could not be continuous. For example, the inner ring 52 is not continuous because it extends us to form a complete circle. On the other hand, the outer ring 54 is continuous. The inner ring and the outer ring could be continuous and in another embodiment the inner ring and the outer ring are not continuous. It is contemplated that the inner ring and the outer ring could be of shapes other than the circular one. For example, the term "ring" as used herein includes non-continuous structures and shapes other than circular. The plurality of electrical connections 60 includes a plurality of outer contact areas 88 (e.g., contact terminals). The plurality of outer contact areas 88 is located radially around the circumference of the automatic calibration circuit 20. The plurality of electrical connections 62 includes a plurality of inner contact areas 86.

The inner contact areas 86 are located close to the center of the circuit 20 than the outer contact areas 88. It is contemplated that the plurality of outer contact areas and inner contact areas could be located in positions different from those shown in Figure 4. The plurality of electrical connections 62 is different from the plurality of electrical connections 60. However, it will be understood that the use of the term "distinct" in this context could only mean that the encoded information is different, although the decoded information is essentially the same. same For example, the instrument 10 could have, essentially, the same calibration characteristics, although the contacts, for example, the bolts 18, which are coupled in with the encoded calibration information are located in different places for each instrument. Accordingly, the encoded calibration information of the first and second instruments corresponding to each instrument is different because the encoded information must be located to be coupled with the appropriate instrument. (In the embodiment shown in Figure 4, the plurality of electrical connections 60 is adapted to be directly directed from each of the plurality of outer contact areas 88 to the respective first common connection (e.g., ring interior 52) or the second common connection (for example, outer ring 54). In this way, the electrical connections of the plurality of outer contact areas 88 are not directed through any of the inner contact areas 86. By having this arrangement, additional independent information of the encoded calibration could be obtained using the same total number of indoor and outdoor contact areas 86, 88 without increasing the size of the automatic calibration circuit 20. In addition, possible undesirable electrical connections could occur if the electrical connections of the outer contact areas (for example, the outer terminals) were directed through the interior contact areas (for example, the inner terminals). However, it is contemplated in another embodiment that the outer contact areas could be directed through the interior contact areas. The plurality of electrical connections 60 is adapted so that it is used by the first instrument to perform the automatic calibration. On the other hand, the plurality of electrical connections 62 is adapted so that it is used by the second instrument to perform the automatic calibration. Therefore, the positioning of the outer contact areas 88 and the inner contact areas 86 allows the automatic calibration circuit 20 to be read by instruments or meters that are capable of making contact with either the plurality of outer contact areas 88 or with the plurality of inner contact areas 86. The information of the plurality of electrical connections 60 corresponds to the plurality of the test sensors 22. The information obtained from the plurality of electrical connections 62 also corresponds to the plurality of test sensors 22. According to one embodiment, substantially all of the plurality of outer contact areas 88 are coupled in an initially electrical manner with the first common connection (e.g. the inner ring 52) and the second common connection (for example, the outer ring 54). To program the automatic calibration circuit, substantially all of the outer contact areas 88 in this embodiment will only be connected to one of the inner or outer rings 52, 54. Similarly, substantially all of the plurality of interior contact areas 86 are connected in an initially electrical manner with the first common connection (e.g., the inner ring 52) and the second common connection (e.g., the outer ring 54). To program the automatic calibration circuit, substantially all of the inner contact areas 86 in this mode will only be coupled with one of the inner or outer rings 52, 54. Figure 4 does not represent a specific pattern, but rather shows a number of possible connections of the plurality of outer and inner contact areas with the first and second common connections. An example of an automatic calibration circuit pattern 20 is shown in Figure 5. It is contemplated that other patterns of the automatic calibration circuit could be formed. Normally, at least one of the outer contact areas 88 and the inner contact area 86 will always be electrically coupled with the first common connection (e.g., inner ring 52) and second common connection (e.g., outer ring 54). For example, as shown in Figures 4 and 5, the outer contact area 88a will always be electrically coupled with the outer ring 54. Similarly, the inner contact area 86a will always be electrically coupled to the ring interior 52. By having individual outer contact areas 88 and inner contact areas 86 only coupled with the inner or outer ring 52, 54, it is aided in the maintenance of a reliable instrument because any "unconnected instrument" could be detected for the software of the instrument. In this way, a defective automatic calibration circuit or a poor connection of the instrument could be detected, so automatic, by the software of the instrument. The instrument could include several responses to the reading of the automatic calibration circuit. For example, responses could include the following codes: (1) correct reading, (2) poor reading, (3) unread code defective, (4) unread circuit missing, and (5) code read out of bounds. A correct reading indicates that the instrument or meter performs the correct reading of the calibration information. Poor reading indicates that the instrument did not correctly read the calibration information encoded in the circuit. In poor reading, the circuit passed the integrity checks. A faulty unread code indicates that the instrument detects that a circuit is present (continuously between two or more automatic calibration bolts), although the circuit code fails in one or more encoding rules (circuit integrity checks). A missing unread circuit indicates that the instrument does not detect the presence of a circuit (without continuity between any of the automatic calibration bolts). A code read out of bounds indicates that the instrument detects an automatic calibration code, although the calibration information is not valid for this instrument. According to another modality, the circuit of Automatic calibration could be used with an instrument. An example of this automatic calibration circuit is shown in Figure 6. An automatic calibration circuit 120 includes an inner ring 152, an outer ring 154 and a plurality of electrical connections 160. It is contemplated that the inner ring or outer ring will not They could be continuous. For example, the inner ring 152 is not continuous because it does not extend to form a complete circle. On the other hand, outer ring 154 is continuous. The inner ring and the outer ring could be continuous and in another embodiment the inner ring and the outer ring are not continuous. It is contemplated that the inner ring and the outer ring could be of different shapes than the circular shape. The plurality of electrical connections 160 includes a plurality of outer contact areas 188 (e.g., contact terminals). The plurality of outer contact areas 188 is located in a radial position around the circumference of the automatic calibration circuit 120. It is contemplated that the plurality of outer contact areas could be placed in different positions from that shown in Figure 6. The plurality of electrical connections 160 is adapted so that it is used by the instrument to perform automatic calibration. The positioning of outer contact areas 188 allows the automatic calibration circuit 120 to be read by instruments or meters that are capable of making contact with the plurality of outer contact areas 188. The information of the plurality of electrical connections 160 corresponds to the plurality of sensors 22. In accordance with one embodiment, substantially all of the plurality of outer contact areas 188 are coupled in an initially electrical manner with the first common connection (e.g., inner ring 152) and the second common connection (e.g. , the outer ring 154). To program the automatic calibration circuit, substantially all of the outer contact areas 188 in this embodiment will only be coupled with one of the inner and outer rings 152, 154. Figure 6 does not represent a specific pattern, but rather shows all the connections possible of the plurality of outer contact areas with the first and second common connections. An example of a pattern of the automatic calibration circuit 120 is shown in Figure 7. It is contemplated that other patterns of the automatic calibration circuit could be formed. Normally, at least one of the outer contact areas 188 will always be in electrical coupling with the first common connection (e.g., inner ring 152) and the second common connection (e.g., outer ring 154). For example, as shown in Figures 6 and 7, the outer contact area 188a is always electrically coupled to the outer ring 154. By having individual outer contact areas 188 only coupled with the inner or outer ring 152, 154 helps maintain a reliable instrument because any "instrument not connected" could be detected by the instrument software. In this way, a defective automatic calibration circuit or a poor connection of the instrument could be detected automatically by the software of the instrument. According to one method, the automatic calibration circuit (e.g., automatic calibration circuits 10, 120) that will be used with at least one instrument could be formed by providing a substrate. In this way, it is contemplated that other automatic calibration circuits with different electrical connections could be formed in addition to those shown in Figures 4-7 by the process of the present invention. Or a catalytic ink or catalytic polymer solution is applied to at least one side of the substrate. Catalytic ink or catalytic polymer solution is used to help define the electrical connections in the substrate. Once the catalytic ink or solution Catalytic polymer is placed on the substrate, the substrate is coated chemically to form the electrical connections in the substrate. The electrical connections carry the automatic calibration information from the test sensor to the instrument or meter. The electrical connections form a pattern that is adapted so that it is used by at least one instrument to perform the automatic calibration. For example, the automatic calibration circuit could be used with an instrument to perform automatic calibration. In another embodiment, the automatic calibration circuit could be used with at least two instruments to perform the automatic calibration in which the first and second instruments are different. The substrate that will be used in the process of forming the automatic calibration circuit could be comprised of a variety of materials. Normally, the substrate is made of an insulated material. For example, the substrate could be formed from a polymeric material. Non-limiting examples of polymeric materials that could be used to form the substrate include polyethylene, polypropylene, oriented polypropylene (OPP), cast polypropylene (CPP), polyethylene terephthalate (PET), ether polyether ketone (PEEK), polyether sulfone (PES), polycarbonate or combinations thereof. In one embodiment, a catalytic ink or catalytic polymer solution adapted to be coated chemically is used. An example of a catalytic ink or catalytic polymer solution is a catalytic polymer that can be printed by an ink jet. Catalytic ink or catalytic polymer solution adapted to be coated chemically could be applied to the substrate through a variety of methods, such as screen printing, gravure printing and ink jet printing. Catalytic ink or catalytic polymer solution includes a thermoset or thermoplastic polymer that allows the production of a catalytic film adhered to the substrate. According to one method, once the catalytic ink or catalytic polymer solution is applied, it is dried or cured. An example of a drying or curing process that could be used is curing through ultraviolet light. The drying process could include drying or curing through the application of thermal heat. Catalytic ink or catalytic polymer solution has catalytic properties that allow coating or coating by chemical means. Now, this film is capable of being coated chemically. Once the catalytic ink has been applied or Catalytic polymer solution in the substrate and that has dried in the process, the substrate is coated by chemical means. The process of coating or coating by chemical means uses a 'redox' reaction (oxidation-reduction) to deposit the conductive metal on the substrate without using an electric current. In general, the conductive metal is placed on the predefined pattern of the resulting catalytic film that has been applied to the substrate. In this way, the conductive metal is deposited on the dried or cured catalytic film that includes the coating catalysis by chemical means. Non-limiting examples of the conductive metals that could be used in the coating or coating by chemical means include copper, nickel, gold, silver, platinum, palladium, rhodium, cobalt, tin, combinations or alloys thereof. For example, a palladium / nickel combination could be used as the conductive metal or a cobalt alloy could be used as the conductive metal. It is contemplated that other metallic materials and alloys thereof could be used in the coating process by chemical means. The thickness of the conductive metallic material could vary, although it is generally about 1 to 100 μ of an inch and more commonly is about 5 to 50 μ of an inch. Normally, the coating process or Chemical coating involves the reduction of a complex metal in an aqueous solution. Typically, the aqueous solution includes a mild or strong reducing agent that varies by metal or bath. A reducing agent that could be used in coating chemically is sodium hypophosphite (NaH2P02). It is contemplated that other reducing agents could be used in the coating process by chemical means. A non-limiting example of this process is represented in connection with Figures 8a-d. In Figure 8a, a substrate 202 having a generally circular shape is provided. It is contemplated that the substrate could be of other sizes and shapes. As shown in Figure 8b, a catalytic ink or catalytic polymer solution 222 is applied to the substrate 202. Then, the substrate 202 with the catalytic ink or catalytic polymer solution 222 is exposed to ultraviolet (UV) light 242 as shown in Figure 8c. After being exposed to the UV242 light, the substrate 202 with the dried or cured chemical catalysed film is then subjected to the chemical coating process. As shown in Figure 8d, the chemical coating process takes place in the bath 262. The substrate could be coated chemically through an autocatalytic or immersion coating process. The substrate 202 is removed and dried to form a circuit of automatic calibration. In this particular example, the automatic calibration circuit is shown in Figure 4. According to another method, the automatic calibration circuit could form electrical connections on two opposite sides. In this method, a substrate is provided. The substrate includes at least one opening formed therethrough. It is desirable that the substrate forms a plurality of openings, which in one embodiment could be referred to as track openings. The openings could be circular in shape with a diameter generally around 5 to 30 thousandths. The plurality of openings could also be of different shapes from the plurality of openings of generally circular shape such as polygonal shapes (eg, square, rectangle) or non-polygonal shapes (eg, oval). The plurality of openings could be formed through a variety of methods including cutting or punching. One method of cutting to form the plurality of openings 102a-d is by the use of a laser. By forming the openings through the substrate, an electrical connection could be formed between the front side and the back side of the substrate. Catalytic ink or catalytic polymer solution is provided on two opposite sides of the substrate. The catalytic ink or catalytic polymer solution is used to help define the electrical connections in the substrate. Once the catalytic ink or catalytic polymer solution is placed on opposite sides of the substrate and subsequently cured or dried, the substrate is chemically coated to form the electrical connections of the substrate. The electrical connections, which are on opposite sides of the substrate, convey the automatic calibration information from at least one test sensor to the instrument or meter. A non-limiting example of this process is represented in connection with Figures 9a-9f. In Figure 9a, a substrate 302 having a generally circular shape is provided. In Figure 9b, a plurality of openings 314 are formed through the substrate 302. The openings 314, as discussed above, could be formed, for example, by a laser. The number, shape or size of the plurality of openings 314 could vary from those depicted in Figure 9b. In Figure 9c, catalytic ink or catalytic polymer solution 322 is applied to a first side 324 of substrate 302. In Figure 9d, catalytic ink or catalytic polymer solution 332 is applied to an opposite second side 334 of substrate 302. illustration of catalytic ink or catalytic polymer solution 322, 332, after being applied on a surface of one of the plurality of openings 314 is shown in Figure 10a. The substrate 302 with the catalytic ink or catalytic polymer solution 322, 332 is exposed to UV light 342 in Figure 9e. After being exposed to UV light 342 in Figure 9e, the substrate is exposed to the chemical coating process. As shown in Figure 9f, the chemical coating process is carried out in the bath 362, which contains a coating solution by chemical means. The substrate could be coated chemically through a process of autocatalytic or immersion coating. The substrate 302 is removed from the bath 362 and dried to form an automatic calibration circuit having electrical connections on both sides that communicate electrically with each other through the plurality of openings 314. Specifically, the localized conductive metal in the plurality of openings 314 establishes the electrical connection between the sides of the substrate 302. This is illustrated for example, in Figure 10b where a coating layer 360 is formed in the catalytic ink or catalytic polymer solution 322, 332 and is also extends and fills, substantially, the opening. The coating layer 360 needs to be in a sufficient quantity and to be suitably located in the opening in order to establish an electrical connection between the sides 324, 334 of the substrate 302. The methods for forming the automatic calibration circuit are adapted to produce high resolution electrical connections in the automatic calibration circuit. Specifically, the method of the present invention allows automatic calibration circuits with lines and spaces of 50 μm or less between the electrical connections. Furthermore, in some embodiments, the automatic calibration circuit is adapted to use both sides of the substrate through the use of the openings to better define the automatic calibration characteristics in the test sensor or in the package. Through the movement of the electrical connections to the other side of the substrate, it is less likely that the instrument or meter pins will cut or join the traces between the different contact terminals. Automatic calibration circuits (e.g., automatic calibration circuits 20, 120) of the present invention could be formed, and subsequently, could be linked with a sensor packet (e.g., sensor pack 12). The automatic calibration circuit could be linked with the sensor package, for example, through an adhesive or other joining method. The automatic calibration circuits 20, 120 of Figures 4-7 are of a generally circular shape. Do not However, it is contemplated that the automatic calibration circuits could be of different shapes than those shown in Figures 4-9. For example, the automatic calibration circuit could be of a square shape, of rectangle, of other polygonal shapes, and of non-polygonal shapes that include the oval shape. It is also contemplated that the contact areas could be in different locations than those represented in Figures 4-9. For example, the contacts could be in a linear series. It is contemplated that the automatic calibration circuits 20, 120 could be used with instruments other than the instrument 10 shown in Figures 1, 2. The automatic calibration circuits 20, 120 could also be used in other types of sensor packages that the sensor pack 12. For example, automatic calibration circuits could be used in such sensor packages. as a cartridge with a stacked plurality of test sensors or a pack of cylinder type sensors. PROCESS A A method of forming an automatic calibration circuit that will be used with a sensor pack, the sensor pack includes at least one test sensor and is adapted so that it is used with an instrument or meter, the method comprises the steps of: providing a substrate; applying a catalytic ink or catalytic polymer solution on at least one side of the substrate, the catalytic ink or catalytic polymer solution is used to help define the electrical connections in the substrate; and chemically coating the substrate where the catalytic ink or catalytic polymer solution was applied to form the electrical connections of the substrate, the electrical connections convey the automatic calibration information from at least one test sensor to the instrument. PROCESS B Process method A, where the substrate is a polymeric material.

PROCESS C Process method B, wherein the polymeric material includes polyethylene, polypropylene, oriented polypropylene (OPP), cast polypropylene (CPP), polyethylene terephthalate (PET), ether polyether ketone (PEEK), polyether sulfone (PES) , polycarbonate or combinations thereof. PROCESS D Process method A, where the chemical coating or coating uses a conductive metal that it is copper, nickel, gold, silver, platinum, palladium, rhodium, cobalt, tin, combinations or alloys thereof. PROCESS E Process method D, where the thickness of the conductive metallic material is approximately 1 to 100 μ of an inch. PROCESS F The process method E, where the thickness of the conductive metallic material is approximately 5 to 50 μ of an inch. PROCESS G The process method A, wherein the catalytic ink or catalytic polymer solution is a catalytic polymer that can be printed by an ink jet. PROCESS H Process method A, where the automatic calibration circuit is adapted so that it is used exactly with one type of instrument. PROCESS I The process method A, wherein the automatic calibration circuit is adapted so that it is used with a plurality of instruments. PROCESS J The process method A, in which the catalytic ink or catalytic polymer solution is applied to the substrate through inkjet printing. PROCESS K The process method A, in which the application of catalytic ink or catalytic polymer solution is placed on the substrate through screen printing. PROCESS L Process method A, where the application of the catalytic ink or catalytic polymer solution is placed on the substrate through gravure printing. PROCESS M The process method A, further comprises the drying or curing of the catalytic ink or catalytic polymer solution. PROCESS N A method of forming an automatic calibration circuit that will be used with a sensor package, the sensor package includes at least one test sensor and is adapted to be used with an instrument or meter, the method comprises stages of: providing a substrate; forming at least one opening through the substrate; applying a catalytic ink or catalytic polymer solution on two opposite sides of the substrate, the catalytic ink or catalytic polymer solution is used to help define the electrical connections in the substrate; Y chemically coating the substrate where the catalytic ink or catalytic polymer solution was applied to form the electrical connections of the substrate, the electrical connections convey the automatic calibration information from at least one test sensor to the instrument. PROCESS OR The process method N, wherein at least one opening is formed by a laser before defining the electrical connections of the substrate. PROCESS P The process method N, wherein at least one opening is formed by punching before defining the electrical connections of the substrate. PROCESS Q The process method N, wherein at least one opening is a plurality of openings. PROCESS R The process method N, where the substrate is a polymeric material. PROCESS S The process method N, where the polymeric material includes polyethylene, polypropylene, oriented polypropylene (OPP), polypropylene emptying (CPP), polyethylene terephthalate (PET), ether polyether ketone (PEEK), sulfone polyether (PES), polycarbonate or combinations thereof. PROCESS T The process method N, wherein the coating or coating by chemical means uses a conductive metal that is copper, nickel, gold, silver, platinum, palladium, rhodium, cobalt, tin, combinations or alloys thereof. PROCESS U The process method T, where the thickness of the conductive metallic material is approximately 1 to 100 μ of an inch. PROCESS V The process method U, where the thickness of the conductive metallic material is approximately 5 to 50 μ of an inch. PROCESS W The process method N, wherein the catalytic ink or catalytic polymer solution is applied to the substrate by inkjet printing. PROCESS X The process method N, where the application of catalytic ink or catalytic polymer solution is placed on the substrate through screen printing. PROCESS AND The process method N, where the application of catalytic ink or catalytic polymer solution is placed in the substrate through gravure printing. PROCESS Z A method of forming a sensor package adapted to be used with at least one instrument to determine the concentration of analyte in a fluid sample, the method comprising the steps of: providing a substrate; applying a catalytic ink or catalytic polymer solution to at least one side of the substrate, the catalytic ink or catalytic polymer solution is used to help define the electrical connections in the substrate, and to chemically coat the substrate where the catalytic ink or Catalytic polymer solution was applied to form the electrical connections of the substrate, the electrical connections convey the automatic calibration information from at least one test sensor to the instrument; join the automatic calibration circuit with the base surface of the sensor package; and providing at least one test sensor that is adapted to receive the fluid sample and that can be operated with at least one instrument. PROCESS AA The process method Z, wherein at least one test sensor is a plurality of sensors and also provides a plurality of cavities containing a respective test sensor of the plurality of test sensors, the plurality of test cavities being located around the automatic calibration circuit. PROCESS BB The process method Z, where the substrate is a polymeric material. PROCESS CC The process method BB, where the polymeric material includes polyethylene, polypropylene, oriented polypropylene (OPP), polypropylene emptying (CPP), polyethylene terephthalate (PET), ether polyether ketone (PEEK), polyether sulfone (PES) , polycarbonate or combinations thereof. DD PROCESS The process method Z, wherein the coating or coating by chemical means uses a conductive metal that is copper, nickel, gold, silver, platinum, palladium, rhodium, cobalt, tin, combinations or alloys thereof. PROCESS EE The process method DD, where the thickness of the conductive metallic material is approximately 1 to 100 μ of an inch. FF PROCESS The EE process method, where the thickness of the conductive metal material is approximately 5 to 50 μ of an inch PROCESS GG The process method Z, where the catalytic ink or catalytic polymer solution is a catalytic polymer that can be printed by ink jet. PROCESS HH The process method Z, where the catalytic ink or catalytic polymer solution is applied to the substrate by inkjet printing. PROCESS II The process method Z, where the application of catalytic ink or catalytic polymer solution is placed on the substrate through screen printing. PROCESS JJ The process method Z, where the application of catalytic ink or catalytic polymer solution is placed on the substrate through gravure printing.

KK PROCESS The process method Z, also comprises the drying or curing of the solution or coating catalysis ink by chemical means. While the present invention has been described with reference to one or more particular embodiments, those skilled in the art will recognize that they could many changes are made therein without departing from the spirit and scope of the present invention. Each of these modalities and the obvious variations thereof is contemplated to fall within the spirit and scope of the invention as defined by the appended claims.

Claims (37)

1. CLAIMS 1. A method of forming an automatic calibration circuit that will be used with a sensor pack, the sensor pack includes at least one test sensor and is adapted to be used with an instrument or meter, characterized in that it comprises the stages of: providing a substrate; applying a catalytic ink or catalytic polymer solution on at least one side of the substrate, the catalytic ink or catalytic polymer solution is used to help define the electrical connections in the substrate; and chemically coating the substrate where the catalytic ink or catalytic polymer solution was applied to form the electrical connections of the substrate, the electrical connections convey the automatic calibration information from at least one test sensor to the instrument.
2. 2. The method according to claim 1, characterized in that the substrate is a polymeric material.
3. The method according to claim 2, characterized in that the polymeric material includes polyethylene, polypropylene, oriented polypropylene (OPP), cast polypropylene (CPP), polyethylene terephthalate (PET), ether polyether ketone (PEEK), polyether sulfone (PES), polycarbonate or combinations thereof.
4. 4. The method according to claim 1, characterized in that the coating by chemical means uses a conductive metal which is copper, nickel, gold, silver, platinum, palladium, rhodium, cobalt, tin, combinations or alloys thereof.
5. 5. The method according to claim 4, characterized in that the thickness of the conductive metallic material is approximately 1 to 100 μ of an inch.
6. 6. The method according to claim 5, characterized in that the thickness of the conductive metallic material is approximately 5 to 50 μ of an inch.
7. The method according to claim 1, characterized in that the catalytic ink or catalytic polymer solution is a catalytic polymer that can be printed by an ink jet.
8. The method according to claim 1, characterized in that the automatic calibration circuit is adapted so that it is used exactly with one type of instrument.
9. The method according to claim 1, characterized in that the automatic calibration circuit is adapted so that it is used with a plurality of instruments.
10. 10. The method according to claim 1, characterized in that the catalytic ink or catalytic polymer solution is applied to the substrate through the ink jet printing.
11. The method according to claim 1, characterized in that the application of the catalytic ink or catalytic polymer solution is placed on the substrate through the screen printing.
12. The method according to claim 1, characterized in that the application of the catalytic ink or catalytic polymer solution is placed on the substrate through the gravure printing.
13. 13. The method according to the claim 1, further characterized in that it comprises the drying or curing of the catalytic ink or catalytic polymer solution.
14. 14. A method of forming an automatic calibration circuit that will be used with a sensor pack, the sensor pack includes at least one test sensor and is adapted to be used with an instrument or meter, characterized in that it comprises the stages of: providing a substrate; forming at least one opening through the substrate; applying a catalytic ink or catalytic polymer solution on two opposite sides of the substrate, the catalytic ink or catalytic polymer solution is used to help define the electrical connections in the substrate; and chemically coating the substrate where the catalytic ink or catalytic polymer solution was applied to form the electrical connections of the substrate, the electrical connections carry the automatic calibration information from at least one test sensor to the instrument.
15. The method according to claim 14, characterized in that at least one opening is formed by a laser before defining the electrical connections of the substrate.
16. The method according to claim 14, characterized in that at least one opening is formed by punching before defining the electrical connections of the substrate.
17. 17. The method according to claim 14, characterized in that at least one opening is a plurality of openings.
18. 18. The method of compliance with the claim 14, characterized in that the substrate is a polymeric material.
19. The method according to claim 18, characterized in that the polymeric material includes polyethylene, polypropylene, oriented polypropylene (OPP), cast polypropylene (CPP), polyethylene terephthalate (PET), ether polyether ketone (PEEK), polyether sulfone (PES), polycarbonate or combinations thereof.
20. 20. The method according to claim 14, characterized in that the chemical coating uses a conductive metal that is copper, nickel, gold, silver, platinum, palladium, rhodium, cobalt, tin, combinations or alloys thereof.
21. The method according to claim 20, characterized in that the thickness of the conductive metallic material is approximately 1 to 100 μ of an inch.
22. 22. The method according to claim 21, characterized in that the thickness of the conductive metallic material is approximately 5 to 50 μ of an inch.
23. 23. The method according to the claim 14, characterized in that the catalytic ink or catalytic polymer solution is applied to the substrate by the ink jet printing.
24. 24. The method according to claim 14, characterized in that the application of the catalytic ink or catalytic polymer solution is placed on the substrate through screen printing.
25. 25. The method according to claim 14, characterized in that the application of the catalytic ink or catalytic polymer solution is placed on the substrate through the gravure printing.
26. 26. A method of forming a sensor package adapted to be used with at least one instrument to determine the concentration of analyte in a fluid sample, characterized comprises the steps of: provide a substrate; applying a catalytic ink or catalytic polymer solution on at least one side of the substrate, the catalytic ink or catalytic polymer solution is used to help define the electrical connections in the substrate; and chemically coating the substrate where the catalytic ink or catalytic polymer solution was applied to form the electrical connections of the substrate, the electrical connections convey the automatic calibration information from at least one test sensor to the instrument; join the automatic calibration circuit with the base surface of the sensor package; and providing at least one test sensor that is adapted to receive the fluid sample and that can be operated with at least one instrument.
27. 27. The method of compliance with the claim 26, characterized in that at least one test sensor is a plurality of sensors and further provides a plurality of cavities containing a respective test sensor of the plurality of test sensors, the plurality of test cavities is located around the calibration circuit automatic
28. 28. The method according to claim 26, characterized in that the substrate is a polymeric material.
29. 29. The method of compliance with the claim 28, characterized in that the polymeric material includes polyethylene, polypropylene, oriented polypropylene (OPP), cast polypropylene (CPP), polyethylene terephthalate (PET), polyether ketone ether (PEEK), polyether sulfone (PES), polycarbonate or combinations thereof.
30. 30. The method according to claim 26, wherein the coating or covering chemically uses a conductive metal being copper, nickel, gold, silver, platinum, palladium, rhodium, cobalt, tin, combinations or alloys thereof .
31. 31. The method according to claim 30, characterized in that the thickness of the conductive metallic material is approximately 1 to 100 μ of an inch.
32. 32. The method according to claim 31, characterized in that the thickness of the conductive metallic material is approximately 5 to 50 μ of an inch.
33. 33. The method according to claim 26, characterized in that the catalytic ink or catalytic polymer solution is a catalytic polymer that can be printed by an ink jet.
34. 34. The method according to claim 26, characterized in that the catalytic ink or catalytic polymer solution is applied to the substrate by inkjet printing. '
35. 35. The method of compliance with the claim 26, characterized in that the application of the catalytic ink or catalytic polymer solution is placed on the substrate through the screen printing.
36. 36. The method according to claim 26, characterized in that the application of the catalytic ink or catalytic polymer solution is placed on the substrate through the gravure printing.
37. 37. The method according to claim 26, further characterized in that it comprises drying or curing the coating catalysis solution or ink chemically.